Merck’s Implanon Tied to Device Migration

The Implanon (etonogestrel implant) birth control, is a small, thin implantable plastic rod that slowly releases etonogestrel. The device is meant to last three years and received U.S. Food and Drug Administration (FDA) clearance one decade ago. Implanon birth control may last longer than three years; however, the three-year time frame is what is recommended to remove the nearly-spent Implanon for replacement, or to switch to an alternative birth control device.

Twelve years prior, a research paper described the difficulty in extracting the six capsules that made up the prior Norplant implantable birth control system. The Implanon implantable birth control followed the Norplant. In the 23 years, concern has risen over similar implantable devices and the challenges in removing the device and device migration.

Implanon birth control is one of the more recent devices approved for long-term, low maintenance birth control by implanting the device subcutaneously (under the skin) in the upper arm. The device is meant to distribute protection from unwanted pregnancy without the user having to remember to take a daily pill or change a birth control patch or other birth control device.

Meanwhile, plaintiffs have alleged, in Implanon birth control personal injury lawsuits, experiencing difficulty locating and extracting the used device at the end of its life cycle. In some cases, the Implanon device migrated away from the original insertion site during the three-to-four years that the device was in place. There are also documented cases in which the Implanon device was located far from the initial insertion point; for instance, in a blood vessel of the lung or where the device could not be located, according to Merck & Company, the maker of the device. One plaintiff alleged wrongful birth, after becoming pregnant.

Merck & Co. through its subsidiary Organon, has released Implanon NXT and Nexplanon, updates to the Implanon device that includes barium sulfate added to the core of the device. Barium sulfate may be seen on X-rays, which helps clinicians locate a difficult-to-locate device.

Problems associated with Implanon have not been sufficient to convince the FDA to mandate a removal of the Implanon implantable device from the market. This, despite a federal regulator mandated warning label update in March 2016 concerning the rare potential for device migration. The FDA indicates that it deems the implantable devices as safe and effective.

Meanwhile, an Implanon birth control consumer fraud lawsuit was brought by a woman from Maine who was implanted with the Implanon birth control device early in 2012 following a recommendation she received from a community health clinic. Approximately 18 months later, when the birth control had only been through less than half of its life cycle, the woman tested positive for pregnancy, gave birth to a child, and became a single mother. Despite repeated attempts, clinicians were unable to locate the device. The lawsuit was filed in the United States District Court, District of Maine over allegations of wrongful birth.

Lawsuits alleging Implanon birth control consumer fraud include that patients were not fully aware of the potential for device migration, or the difficulty often faced when attempting to remove the device.

Meanwhile, 20 years prior, a paper was published describing the difficulty in locating and removing the six capsules that were part of the Norplant device, which is no longer in use. “A case study was presented of one woman who asked for removal of the six small Norplant capsules (2.4 mm x 34 mm) that were inserted sub dermally, radially in the medial portion of the upper arm, per standard protocol,” the paper indicated. “The obstetrician made a surgical incision and removed easily five of the capsules, but could not locate the last one by digital probing. The patient was then referred to a hospital radiology department. The first action taken was a radiograph, which revealed a faint visualization. The second picture was taken with real time sonography, but the capsule could not be visualized. A third action was a computed tomography of multiple thin (3 mm) slices, but again there was no success in locating the missing capsule. The final attempt was to use intermittent fluoroscopy and persistent probing, which revealed the locale and led to successful removal of the last capsule.”

In all, it took four attempts to locate and remove the sixth Norplant capsule. Wyeth, the maker of Norplant, withdrew the device from the market six years later, in 2000, and was facing a number of lawsuits over the product. Six years after that, the FDA cleared Implanon, without mentioning the potential for device migration until ten years later in 2016. Norplant was implanted in a similar way to the single-application Implanon, which has one rod or capsule.

Now indicated in the listing of Implanon birth control side effects is that “Implants have been reported to be found in a blood vessel including a blood vessel in the lung.” Although the statement does not specifically reference device migration, it is inferred given the distance between the inner upper arm and the lung. Device migration is later addressed in the second paragraph on page eight under a sub-head “Problems with Insertion and Removal” that states, “Location and removal of the implant may be difficult or impossible because the implant is not where it should be. Special procedures, including surgery in the hospital, may be needed to remove the implant. If the implant is not removed, then the effects of IMPLANON (sic) will continue for a longer period of time. Implants have been found in the pulmonary artery (a blood vessel in the lung). If the implant cannot be found in the arm, your healthcare professional may use imaging methods on the chest. If the implant is located in the chest, surgery may be needed.”

Legal Advice and Information Regarding Implanon

If you or someone you know suffered injuries associated with the Implanon birth control device, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).